AsthmaPhase 1NCT02140320
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of RV1729 for up to 28 Days
A Phase 1 study testing RV1729 single dose, RV1729 14 day repeat dose and RV1729 28 day repeat dose in people with Asthma and Healthy Volunteers, run by Respivert Ltd at 2 sites in United Kingdom.
Trial summary
RV1729 is a new medicine being developed for the potential treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The objective of this study is to investigate the safety, tolerability and pharmacokinetics of single doses of RV1729 and repeat doses of RV1729… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Healthy Volunteers
- What is being tested?
- RV1729 single dose, RV1729 14 day repeat dose and RV1729 28 day repeat dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2014to Mar 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a man or woman between 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- Cohorts 1, 2 \& 3 women of childbearing potential must have a documented menstrual period prior to the first dose and be willing to use 2 forms of appropriate methods of contraception from screening until 4 months after the final dose of RV1729, OR
- Women of non-childbearing potential must be spontaneously amenorrhoeic for at least 1 year or have been permanently sterilised, OR
- If a man, must be willing and able to use one of the contraception methods listed in the protocol and agree not to donate sperm from screening until 4 months after the final dose of RV1729
- Women must agree not to donate eggs (ova, oocytes) from screening until at least 6 months after the final dose of RV1729
- Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
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- Body mass index between 19 and 30 kg/m2 and body weight not less than 50 kg.
- Vital sign assessments within normal ranges
- Have a 12-lead ECG recording consistent with normal cardiac function
- Capable of complying with all study restrictions and procedures including ability to use the study inhaler correctly
- Cohorts 1, 2 \& 4 (healthy volunteers only)
- Healthy as determined by a physician, based on a full medical evaluation including medical history, physical examination and laboratory tests.
- Pre-bronchodilator spirometry readings (FEV1 and FVC) to be ≥80% predicted value and FEV1/FVC ratio >0.7
- Not taking prescription medications for 14 days prior to screening and agree not to use prescription medications throughout the duration of the study (with the exception of the use of contraceptives or hormone replacement therapy).
- Not taking over-the-counter medications and herbal medication for 14 days prior to screening throughout the study.
- Cohort 3 (asthma patients only)
- Documented history of asthma, at least 6 months prior to screening and currently being treated with daily inhaled corticosteroids with or without long acting beta-agonist (LABA)
- Have a diagnosis of asthma. This will be confirmed by bronchodilator reversibility at screening
- Have a pre-bronchodilator FEV1 ≥60% and ≤85% of predicted normal value
- Have stable asthma based with no exacerbation requiring change in therapy for 12 weeks and no hospitalisation or visit to accident and emergency for asthma in the 12 months prior to screening.
- Not have a clinical abnormality or laboratory parameters outside the reference range.
- Not taking prescription medications for 14 days prior to screening and agree not to use prescription medications throughout the duration of the study except for use of contraceptives or hormone replacement therapy and treatment for asthma
- Not taking over-the-counter medications and herbal medication for 14 days, or antihistamines for 7 days prior to the screening visit and agree to refrain from taking such medications throughout the study.
Who cannot join
- Upper or lower respiratory tract infection within 4 weeks before screening
- Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening or Day -1
- Has a history of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
- History of, or a reason to believe a subject has a history of drug or alcohol abuse within the past 5 years.
- Positive test for alcohol or drugs of abuse, including cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines or barbiturates at screening or on Day -1
- History of clinically significant allergies that, in the opinion of the Investigator or Medical Monitor, would contraindicate their participation.
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- Subjects known to suffer from hayfever, or other allergy, that may require antihistamine therapy during the course of the study.
- Known allergy to the study drug or any of the excipients of the formulation or has previously been exposed to RV1729.
- Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months or intention to donate blood or blood products during the study.
- Received an experimental drug or used an experimental medical device within 3 months or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled.
- If a woman has a positive serum pregnancy test at screening or a positive urine pregnancy test on Day -1, is pregnant, breast-feeding or planning to become pregnant during the study.
- Liver function test results >1.5 x ULN (upper limit of normal) at Screening or on Day -1.
- Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus (HBV) infection or hepatitis C antibodies.
- History of smoking or use of nicotine-containing substances within the previous 6 months, or a positive carbon monoxide test at screening or on Day -1 (or a smoking history ≥ 10 pack years).
- Preplanned surgery or procedures that would interfere with the conduct of the study.
- Employee of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees or the Investigator.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of regular alcohol consumption within 6 months of the study.
- The subject is unable or unwilling to comply fully with the study protocol.
- Subject is mentally or legally incapacitated.
- Unable or unwilling to undergo multiple venepuncture procedures or the subject has poor access to veins suitable for cannulation.
- Any other reason that the Investigator considers makes the subject unsuitable to participate.
- Cohorts 1, 2 \& 4 (healthy volunteers only)
- Any chronic illness or clinically relevant abnormality identified on the screening medical assessment, laboratory tests or ECG
- Cohort 3 (asthma patients only)
- Administration of oral, injectable or dermal steroids or leukotriene modifiers within 3 months or intranasal steroids within 1 week of the screening visit.
- Has ever had an episode of life-threatening asthma defined as respiratory arrest, intubation for asthma, or intensive care unit admission for asthma.
- Any acute or chronic illness or clinically relevant abnormality other than asthma identified on the screening medical assessment, laboratory tests or ECG.
- Has severe asthma based on Investigator assessment and/or use of prohibited asthma medications.
- Cohort 4 (healthy volunteers only)
- Women of child bearing potential
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Study site
London, NW10 7EW
Study site
Manchester, M23 9QZ
About this study
Official title: A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV1729 in Healthy Subjects for up to 28 Days and Subjects With Stable Asthma for 14 Days
RV1729 is a new medicine being developed for the potential treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD).
The objective of this study is to investigate the safety, tolerability and pharmacokinetics of single doses of RV1729 and repeat doses of RV1729 for up to 28 days.
- Conditions
- Asthma, Healthy Volunteers
- Being tested
- RV1729 single dose, RV1729 matching placebo single dose, RV1729 14 day repeat dose, RV1729 matching placebo 14 day repeat dose, RV1729 28 day repeat dose
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV1729 single doseDrug
Safety and tolerability of single dose
RV1729 matching placebo single doseDrug
Safety and tolerability of single dose
RV1729 14 day repeat doseDrug
Safety and tolerability of repeat doses
RV1729 matching placebo 14 day repeat doseDrug
Safety and tolerability of repeat doses
RV1729 28 day repeat doseDrug
Safety and tolerability of repeat doses
RV1729 matching placebo 28 day repeat doseDrug
Safety and tolerability of repeat doses
| Study group | Role | What they receive |
|---|---|---|
| Single dose (healthy volunteers) | Experimental | Not described Receives: Drug: RV1729 single dose; Drug: RV1729 matching placebo single dose |
| 14 day repeat dose (healthy volunteers) | Experimental | Not described Receives: Drug: RV1729 14 day repeat dose; Drug: RV1729 matching placebo 14 day repeat dose |
| 14 day repeat dose (asthma patients) | Experimental | Not described Receives: Drug: RV1729 14 day repeat dose; Drug: RV1729 matching placebo 14 day repeat dose |
| 28 day repeat dose (healthy volunteers) | Experimental | Not described Receives: Drug: RV1729 28 day repeat dose; Drug: RV1729 matching placebo 28 day repeat dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Assessment of the number of adverse events reported by subjects following dosing
Measured: Cohort 1, 56 days: Cohorts 2 & 3, 70 days: Cohort 4, 84 days
ECG assessment (12-lead ECG)
Change from pre-dose values
Measured: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Vital sign assessment (blood pressure and heart rate, measured together)
Change from pre-dose values
Measured: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Clinical laboratory assessments (blood and urine samples, collected together)
Change from pre-dose values
Measured: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Spirometry assessment (FEV1 & FVC)
Change from pre-dose values
Measured: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Secondary outcomes (1)
Plasma RV1729 levels
Measured: Cohort 1: Day 1, 7 samples, Day 2-29, 5 samples; Cohorts 2 & 3: Days 1, 7 & 14, 8 samples, Days 2 & 8-13, 1 sample per day, Days 15-42, 6 samples; Cohort 4: Days 1, 14 & 28, 8 samples, Days 2, 7, 15, 21, 26 & 27, 1 sample per day, Days 29-70, 7 samples;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivert Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liza O'Dowd, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140320
- Sponsor's protocol ID
- STN003
- Other IDs
- 2014-000090-39, 2014
- Status last verified
- Apr 2015
- First submitted
- 14 May 2014
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV1729 in Healthy Subjects for up to 28 Days and Subjects With Stable Asthma for 14 Days
- ClinicalTrials.gov ID
- NCT02140320
- Acronym / sponsor ID
- STN003
- Conditions
- Asthma, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Respivert LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RV1729 is a new medicine being developed for the potential treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD).
The objective of this study is to investigate the safety, tolerability and pharmacokinetics of single doses of RV1729 and repeat doses of RV1729 for up to 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single dose (healthy volunteers) | Experimental | Drug: RV1729 single dose, Drug: RV1729 matching placebo single dose |
| 14 day repeat dose (healthy volunteers) | Experimental | Drug: RV1729 14 day repeat dose, Drug: RV1729 matching placebo 14 day repeat dose |
| 14 day repeat dose (asthma patients) | Experimental | Drug: RV1729 14 day repeat dose, Drug: RV1729 matching placebo 14 day repeat dose |
| 28 day repeat dose (healthy volunteers) | Experimental | Drug: RV1729 28 day repeat dose, Drug: RV1729 matching placebo 28 day repeat dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Be a man or woman between 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- Cohorts 1, 2 \& 3 women of childbearing potential must have a documented menstrual period prior to the first dose and be willing to use 2 forms of appropriate methods of contraception from screening until 4 months after the final dose of RV1729, OR
- Women of non-childbearing potential must be spontaneously amenorrhoeic for at least 1 year or have been permanently sterilised, OR
- If a man, must be willing and able to use one of the contraception methods listed in the protocol and agree not to donate sperm from screening until 4 months after the final dose of RV1729
- Women must agree not to donate eggs (ova, oocytes) from screening until at least 6 months after the final dose of RV1729
Key exclusion criteria (31 listed)
- Upper or lower respiratory tract infection within 4 weeks before screening
- Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening or Day -1
- Has a history of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
- History of, or a reason to believe a subject has a history of drug or alcohol abuse within the past 5 years.
- Positive test for alcohol or drugs of abuse, including cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines or barbiturates at screening or on Day -1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV1729 single doseSafety and tolerability of single dose | Drug | Single dose (healthy volunteers) |
| RV1729 matching placebo single doseSafety and tolerability of single dose | Drug | Single dose (healthy volunteers) |
| RV1729 14 day repeat doseSafety and tolerability of repeat doses | Drug | 14 day repeat dose (asthma patients), 14 day repeat dose (healthy volunteers) |
| RV1729 matching placebo 14 day repeat doseSafety and tolerability of repeat doses | Drug | 14 day repeat dose (asthma patients), 14 day repeat dose (healthy volunteers) |
| RV1729 28 day repeat doseSafety and tolerability of repeat doses | Drug | 28 day repeat dose (healthy volunteers) |
| RV1729 matching placebo 28 day repeat doseSafety and tolerability of repeat doses | Drug | 28 day repeat dose (healthy volunteers) |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: Cohort 1, 56 days: Cohorts 2 & 3, 70 days: Cohort 4, 84 days
Assessment of the number of adverse events reported by subjects following dosing
ECG assessment (12-lead ECG)
Time frame: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Change from pre-dose values
Vital sign assessment (blood pressure and heart rate, measured together)
Time frame: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Change from pre-dose values
Clinical laboratory assessments (blood and urine samples, collected together)
Time frame: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Change from pre-dose values
Spirometry assessment (FEV1 & FVC)
Time frame: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Change from pre-dose values
1 secondary outcome
Plasma RV1729 levels
Time frame: Cohort 1: Day 1, 7 samples, Day 2-29, 5 samples; Cohorts 2 & 3: Days 1, 7 & 14, 8 samples, Days 2 & 8-13, 1 sample per day, Days 15-42, 6 samples; Cohort 4: Days 1, 14 & 28, 8 samples, Days 2, 7, 15, 21, 26 & 27, 1 sample per day, Days 29-70, 7 samples;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liza O'Dowd, MD study director
Sponsor GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RV1729 single dose, RV1729 14 day repeat dose and RV1729 28 day repeat dose in people with Asthma and Healthy Volunteers, run by Respivert Ltd at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (time frame: Cohort 1, 56 days: Cohorts 2 & 3, 70 days: Cohort 4, 84 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.